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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Alta Bates Medical Center 26-Jun-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700

WARNING LETTER
June 26, 2001
Via Federal Express

Pemy Miller
Alta Bates Medical Center
3001 Colby Street
Berkeley, CA 94705

Dear Penny Miller:

We are writing to you because on June 6, 2001, your facility at 2450 Ashby Avenue, Berkeley, CA, was inspected by a representative of the State of California acting in behalf of the Food and Drug Administration (FDA). This inspection revealed a serious regulatory problem involving the mammography at your facility.

Under a United States Federal law, the Mammography Quality Standards Act of 1992, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The inspection revealed the following level 1 finding at your facility:

- Level 1: Mammograms were processed in processor 1, [redacted] room Main Darkroom at site Alta Bates Medical Center, of limits on at least 5 days

The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. This problem is identified as Level 1, because it identifies a failure to meet a significant MQSA requirement.

Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents a serious violation of the law which may result in FDA taking regulation action without further notice to you. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction, charging your facility for the cost of on-site monitoring, assessing civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA Standards, suspension or revocation of your facility?s FDA certificate, or obtaining a court injunction against further mammography. In addition, your response should address the Level 2 findings that were listed on the inspection report provided to you at the close of the inspection. A finding marked with an (R) indicates that the finding or violation was cited during the previous inspection. A finding is considered a repeat finding if the same type of violation was cited during the previous inspection, whether or not the finding is associated with the same piece of equipment or the same personnel in a given category. These Level 2 findings are:

- Level 2: 2 of 7 random reports reviewed did not contain an acceptable assessment category for site Alta Bates Medical Center (R)

- Level 2: The facility has not specified adequate written procedures for collecting and resolving consumer complaints or did not follow them when required at site Alta Bates Medical Center (R)

- Level 2: Corrective actions for processor QC failures were not documented at least once for processor 1, [redacted] Main Darkroom at site Alta Bates Medical Center(R)

- Level 2: The time period between the previous and current surveys for x-ray unit 2, [redacted] exceeds 14 months

It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days from the date you received this letter:

  • the specific steps you have taken to correct all of the violations noted in this letter;
  • each step your facility is taking to prevent the recurrence of similar violations;
  • equipment settings (including technique factors), raw test data, and calculated final results, where appropriate; and
  • sample records that demonstrate proper record keeping procedures, if the findings relate to quality control or other records (Note: Patient names or identification should be deleted from any copies submitted).*

*This note is not applicable for letters which also address patient notification.

Please submit your response to:

Russell A. Campbell, Compliance Officer
San Francisco District
U.S. Food and Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502

Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA?s requirements for mammography facilities by contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov

If you have more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Russell A. Campbell at 510-337-6861.

Sincerely yours,

/s/
Dennis K. Linsley
District Director